BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER BARRICOR LH PLASMA BLOOD COLLECTION TUBES

    MDR report key: 10984340 · Received December 10, 2020

    Report

    Report Number
    9617032-2020-01031
    Event Type
    Malfunction
    Date Received
    December 10, 2020
    Date of Event
    November 20, 2020
    Report Date
    September 2, 2021
    Manufacturer
    BECTON, DICKINSON AND COMPANY (BD)
    Product Code
    JKA
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H6: INVESTIGATION SUMMARY A RECENT STUDY WAS CONDUCTED TO INVESTIGATE THE CUSTOMERS REPORTED ISSUE OF ASPIRATION ERRORS ON THE ATELLICA SYSTEM WHILE USING BD BARRICOR TUBES. TO INVESTIGATE THE REPORTED FAILURE THE FOLLOWING TESTING WAS PERFORMED: FUNCTIONAL TESTING WAS CONDUCTED ON RETENTION SAMPLES FROM MATERIAL #365053, LOT# 015156, 3.5ML BARRICOR TUBES. TESTING INCLUDED BLOOD DRAWN FROM SUBJECTS AND BAGGED BLOOD, NO ASPIRATION ERRORS WERE OBSERVED. FUNCTIONAL TESTING WAS CONDUCTED ON RETURNED SAMPLES, MATERIAL# 365056 LOT# 0311963, 5.5ML BARRICOR TUBES. DURING THIS TESTING BLOOD WAS DRAWN FROM SUBJECTS AND NO ASPIRATION ERRORS WERE DETECTED. IN ADDITION TO THE RETURNED SAMPLES RETENTION SAMPLES FROM MATERIAL# 365056 LOT# 0170952, 5.5 ML BARRICOR, AND MATERIAL# 365056 LOT# 0070862, 5.5 ML BARRICOR WERE TESTED USING FRESH AND BAGGED BLOOD. TWO SAMPLES FROM LOT# 0070862 HAD ASPIRATION ERRORS AND WERE OBSERVED TO HAVE MICRO-CLOTS POTENTIALLY FROM THE BAGGED BLOOD. THE ANALYTE PROBE WAS CLEAN AFTER THE RUN AND NO OTHER ASPIRATION ERRORS WERE OBSERVED. BD INVESTIGATED A SAMPLE PROBE FROM THE IN-HOUSE ATELLICA SYSTEM AND, A RETURNED SAMPLE PROBE FROM THE CUSTOMER. BOTH PROBES WERE INSPECTED USING A MICROSCOPE, AND A MATERIALS ANALYSIS WAS CONDUCTED TO DETERMINE WHETHER ANY SIGNIFICANT MATERIAL ACCUMULATION MIGHT CONTRIBUTE TO ASPIRATION ERRORS. UPON INSPECTION, BOTH PROBES APPEARED CLEAN AFTER THE RUNS AND, NO CORRELATION WAS OBSERVED BETWEEN THE PROBE PARTICULATES AND ASPIRATION ERRORS. AFTER EXTENSIVE FUNCTIONAL TESTING, ANALYSIS OF AN ATELLICA INTERNAL SAMPLE PROBE, AND ANALYSIS OF THE CUSTOMER RETURNED SAMPLE PROBE, BD WAS NOT ABLE TO REPLICATE THE REPORTED FAILURE OR IDENTIFY ROOT CAUSE. A REVIEW OF THE DEVICE HISTORY RECORDS FOR THE INCIDENT LOT WAS CONDUCTED AND, ALL PRODUCT SPECIFICATIONS AND REQUIREMENTS FOR LOT RELEASE WERE MET. THERE WERE NO RELATED QUALITY ISSUES DURING MANUFACTURING OF THE PRODUCT. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. OUR BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS. H3 OTHER TEXT : SEE H10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE USING BD VACUTAINER® BARRICOR¿ LH PLASMA BLOOD COLLECTION TUBES, CANNOT ASPIRATE FROM THE TUBE USING ANALYZER. PATIENT IMPACT WAS NOT REPORTED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM FRENCH TO ENGLISH: THE HOSPITAL OF ARRAS HAS BEEN EQUIPPED WITH THE SIEMENS ATELLICA SOLUTION FOR OVER A YEAR. I HAVE IMPLANTED THE BARRICOR TUBES SINCE (B)(6) 2020 AND THE CH IS FACING THE SAME PROBLEMS AS THE AMIENS UNIVERSITY HOSPITAL WITH A REJECTION RATE EVEN GREATER THAN THE UNIVERSITY HOSPITAL IS AROUND 70% REJECTION. WE WERE AT CH ARRAS THIS AFTERNOON WITH YUHANNES TO UNDERSTAND THESE PROBLEMS. AS AT THE UNIVERSITY HOSPITAL OF AMIENS WHEN THEY REPLAY THE TUBES MANUALLY, IT WORKS. THE PEOPLE AT SIEMENS KEEP TELLING BIOLOGISTS AND EXECUTIVES THAT THE BARRICOR IS NOT VALIDATED ON THE ATELLICA SOLUTION, THE SPEECH IS CONTRADICTORY WITH THEIR WORDS AT THE MARSEILLE APHM WHICH MUST PASS ON THIS SAME SOLUTION OF HERE 1 TO 2 YEARS. FOR INFORMATION, WE TRIED TO COOL DOWN THE SITUATION AND WE ASKED THE CH TO WAIT UNTIL WE HAVE OUR CALL WITH THE CHU AMIENS AND SIEMENS IN ORDER TO FIND A SOLUTION. COULD YOU PLEASE GIVE ME MORE DETAILS ABOUT THE DEFECT FOUND, WHAT IS MEANT BY "TUBE REJECTION"? THE TUBE IS PRESENTED TO THE ANALYSER. THE ANALYSER REJECTS IT EVEN THOUGH THE CORRECT VOLUME OF BLOOD IS SAMPLED. THE ANALYSER REJECTS IT (BY PLACING IT IN THE ERROR EXIT AREA) WITH THE ERROR "SAMPLE INTEGRITY ERROR." WERE THERE ANY PATIENT OR MEDICAL STAFF CONSEQUENCES? NONE AT ALL. THIS LEADS TO ADDITIONAL ACTIONS/TACHES FOR THE LABORATORY TECHNICIANS.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. DEVICE MANUFACTURE DATE: UNKNOWN. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHILE USING BD VACUTAINER® BARRICOR¿ LH PLASMA BLOOD COLLECTION TUBES, CANNOT ASPIRATE FROM THE TUBE USING ANALYZER. PATIENT IMPACT WAS NOT REPORTED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM (B)(6) TO ENGLISH: THE HOSPITAL OF (B)(6) HAS BEEN EQUIPPED WITH THE SIEMENS ATELLICA SOLUTION FOR OVER A YEAR. I HAVE IMPLANTED THE BARRICOR TUBES SINCE (B)(6) 2020 AND THE CH IS FACING THE SAME PROBLEMS AS THE (B)(6) HOSPITAL WITH A REJECTION RATE EVEN GREATER THAN THE UNIVERSITY HOSPITAL IS AROUND 70% REJECTION. WE WERE AT CH (B)(6) THIS AFTERNOON WITH (B)(6) TO UNDERSTAND THESE PROBLEMS. AS AT THE UNIVERSITY HOSPITAL OF (B)(6) WHEN THEY REPLAY THE TUBES MANUALLY, IT WORKS. THE PEOPLE AT (B)(6) KEEP TELLING BIOLOGISTS AND EXECUTIVES THAT THE BARRICOR IS NOT VALIDATED ON THE ATELLICA SOLUTION, THE SPEECH IS CONTRADICTORY WITH THEIR WORDS AT THE MARSEILLE APHM WHICH MUST PASS ON THIS SAME SOLUTION OF HERE 1 TO 2 YEARS. FOR INFORMATION, WE TRIED TO COOL DOWN THE SITUATION AND WE ASKED THE CH TO WAIT UNTIL WE HAVE OUR CALL WITH THE CHU (B)(6) AND (B)(6) IN ORDER TO FIND A SOLUTION. COULD YOU PLEASE GIVE ME MORE DETAILS ABOUT THE DEFECT FOUND, WHAT IS MEANT BY "TUBE REJECTION"? THE TUBE IS PRESENTED TO THE ANALYSER. THE ANALYSER REJECTS IT EVEN THOUGH THE CORRECT VOLUME OF BLOOD IS SAMPLED. THE ANALYSER REJECTS IT (BY PLACING IT IN THE ERROR EXIT AREA) WITH THE ERROR "SAMPLE INTEGRITY ERROR". WERE THERE ANY PATIENT OR MEDICAL STAFF CONSEQUENCES? NONE AT ALL. THIS LEADS TO ADDITIONAL ACTIONS/TACHES FOR THE LABORATORY TECHNICIANS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1448614 BD VACUTAINER BARRICOR LH PLASMA BLOOD COLLECTION TUBES BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON, DICKINSON AND COMPANY (BD) UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1